Kornimate/medical-research-clean huggingface dataset:
evaluating the feasibility of a digital health coaching program for individuals following car t therapy

Conditions: Lymphoma; Lymphoma, B-Cell; Leukemia; Multiple Myeloma; Mantle Cell Lymphoma; Follicular Lymphoma; Leukemia, Acute Lymphoblastic

Summary: the aim of this study is to evaluate the feasibility of a digital health coaching program for, and to describe quality of life of, individuals in the 6 months following chimeric antigen receptor (car) t cell therapy. up to 50 english-speaking individuals aged 18 and older who are to receive treatment with a car t cell therapy will be enrolled, all at the university of texas md anderson cancer center. participants must have internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments and will be excluded if they are unable to provide informed consent or have a prognosis of 6 months or less. consented participants will be enrolled in a 6-month digital health coaching program delivered via weekly calls from a health advisor coupled with the digital delivery of content. the program focuses on identification and escalation of treatment-related toxicity, communication with providers, and physical and psychosocial health following treatment. health related quality of life (hrqol) will be assessed with the functional assessment of cancer therapy-lymphoma (fact-l), health self-efficacy will be assessed by the cancer behavior inventory-brief (cbi-b), physical and mental health outcomes will be measured by the national institutes of health (nih) patient reported outcomes measurement information system (promis) global health 10. patient experience in managing car t specific care will be assessed with a 5-item questionnaire developed specifically for use in this study, focused on participants' confidence in understanding, identifying and managing symptoms, and communicating with providers. study outcomes will contribute to knowledge about if and how a digital health intervention may be used to support individuals post-car t cell therapy.


Eligibility criteria:
inclusion criteria: * adults aged 18 and older * able to read, speak and consent in english * confirmed treatment with any commercially available or investigational car t cell therapy. * internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments. * ability to engage in physical activity as evidenced by an eastern cooperative oncology group (ecog) performance status score of less than or equal to 2 exclusion criteria: * individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment) * individuals for whom there is documentation of inability to provide consent in the medical record. * non-english speaking/reading individuals.

Keywords: receptors, chimeric antigen adult hematologic neoplasms digital health coaching
study of sgn-15, antibody-drug conjugate, to treat hormone refractory prostate cancer

Conditions: Prostatic Neoplasms

Summary: sgn-15 is being investigated for therapy of patients with prostate cancer in combination with the cytotoxic agent, taxotere. the study is an open label, randomized phase ii study for patients with documented hormone refractory prostate cancer who have not had any prior therapy with taxotere or novantrone. both sgn-15 and taxotere will be administered weekly over two 6 week courses separated by a 2 week rest period.

the purpose of this study is to evaluate a new class of biologic agent, the monoclonal antibody (mab) drug conjugate sgn-15 (cbr96 - doxorubicin immunoconjugate), used in combination with the taxane agent, taxotere (docetaxel) as a strategy for targeting advanced stage, hormone refractory prostate carcinoma (hrpc). this is a randomized, open label, phase ii study evaluating the immunoconjugate sgn-15 in combination with the taxane taxotere in comparison to taxotere alone in patients with hrpc. based on a previous phase i study of the sgn-15/taxotere combination, the weekly dose of sgn-15 will be 200 mg/m2 and the weekly dose of taxotere will be 35 mg/m2. the schedule of administration for both agents will be weekly, with sgn-15 administered prior to the taxotere in the patients treated with the combination. a single course of therapy will be defined as 6 weekly doses followed by a 2 week rest period for a total of 8 weeks. the study will perform an interim analysis of the data after 80 patients have completed two courses. patients should be treated for a minimum of 2 courses of therapy. additionally, for patients who remain eligible and have experienced tolerable levels of drug toxicity, repeat dosing with subsequent cycles is possible. patients will be removed from study if there is evidence of tumor progression or intolerable toxicity. follow-up assessments include adverse event reporting, clinical laboratory studies, and quality of life (qol) assessment using a validated qol instrument.

Eligibility criteria:
brief: patients must have pathologically confirmed prostate cancer, which is refractory to hormone therapy. there must be evidence of advancing disease, determined by increasing bidimensional or unidimensional measurable tumor or an increasing psa with documented metastatic disease. patients must have lewis(y) antigen expression documented by immunohistochemistry on archived or fresh tumor specimen.

Keywords: prostate lewis blood-group system antibodies, monoclonal antigens, neoplasm antineoplastic agents
clinical and economic outcomes of oral anticoagulants in non-valvular atrial fibrillation

Conditions: Non-Valvular Atrial Fibrillation

Summary: the primary objectives of this study are to compare the risk of major bleeding and stroke/systemic embolism (se) events among oral anticoagulant (oac)-naïve non-valvular atrial fibrillation (nvaf) patients initiating oac warfarin or apixaban or dabigatran or rivaroxaban treatment.


Eligibility criteria:
inclusion criteria: 1. had 1 or more pharmacy claim for apixaban or warfarin or dabigatran or rivaroxaban during the identification period (01-jan-2013 to 30-sep-2015). the first oac pharmacy claim date during the identification period will be designated as the index date 2. patients 18 years old or older as of the index date 3. at least 1 diagnosis of atrial fibrillation prior to or on index date, identified by any medical claim 4. at least 12 months of baseline period prior to index date with continuous enrollment exclusion criteria: 1. evidence of valvular heart disease, transient atrial fibrillation, venous thromboembolism during the 12-month baseline period or on the index date 2. evidence of pregnancy during the study period 3. had a pharmacy claim for warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 12-month baseline period 4. had more than 1 oral anticoagulant claim on the index date
feasibility, tolerability and efficacy of the ketogenic diet in children with drug-resistant epilepsy in south vietnam

Conditions: Drug Resistant Epilepsy; Ketogenic Diet; Feasibility; Tolerability; Efficacy; Children

Summary: according to the world health organization, more than 50 million people have epilepsy. among them, nearly 80% of epileptic patients live in developing countries and 75% of them do not have access to treatment. the ketogenic diet (kd) has been shown as an effective alternative for patients with drug-resistant epilepsy. although it has been studied by few studies in asia, no such studies have been conducted in vietnam. the purpose of this study was to verify the feasibility, tolerability, and efficacy of the kd in children with refractory epilepsies followed at a pediatric center in south vietnam.

children with drug-resistant epilepsy followed at children's hospital no.2, viet nam treated by kd were included in a prospective study from june 2019 to october 2021. side-effects, retention rate, number, and duration of seizures were recorded after 1, 3, 6, 9, and 12 months of kd. patients were considered as responders when a 50% seizure frequency was reached. tolerance and acceptability of the kd were closely monitored.

Eligibility criteria:
inclusion criteria: * age from 1 to 10 years at the time of enrolment, * drug-resistant epilepsy according to the 2010 ilae criteria, * an indication for a ketogenic diet trial according to the 2018 ilae recommendations exclusion criteria: - clinical or laboratory features suggesting an underlying disease contra-indication the use of a ketogenic diet

Keywords: drug resistant epilepsy ketogenic diet
efficacy of exclusive enteral nutrition in adult active crohn's disease

Conditions: Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment

Summary: the study aimed to prove een is effective for inducing early clinical remission, mucosal healing, promoting fistula closure and reducing the size of abscess to adult cd patients. they plan to include about 50 patients and observe the effect of een.


Eligibility criteria:
inclusion criteria: * \>18 years old * patients with cd was diagnosed clinically according to previously established international criteria \[9\] * the diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, ct enterography (cte), and endoscopy. the bowel stricture should mainly cause by inflammation but not fibrosis. exclusion criteria: * patients do not macth the inclusion criteria and those who refuse to taking part in the study
comparison of nn1250 versus insulin detemir, both combined with insulin aspart in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in japan. the aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (nn1250, siba) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * subjects with type 1 diabetes mellitus more than one year * current treatment: basal (once daily at bedtime) - bolus (three times a day just before main meals) regimen only for at least 12 weeks using a long-acting insulin analogue excluding insulin detemir or intermediate-acting insulin as a basal insulin and novorapid® as bolus insulin (a brand of basal insulin preparation has not been changed in the preceding 12 weeks) * hba1c below 10.0% * body mass index (bmi) below 30.0 kg/m\^2 exclusion criteria: * known hypoglycaemia unawareness or recurrent major hypoglycaemia * current treatment with total insulin dose of more than 100 u or iu/day * current treatment or expected to start treatment with systemic corticosteroid
tta in treatment of diabetes and dyslipidemia

Conditions: Type 2 Diabetes Mellitus; Dyslipidemia

Summary: the aim of the study is to evaluate the short-term effects of tetradecylthioacetic acid (tta) on plasma lipids and glucose in male patients with type 2 diabetes mellitus and dyslipidemia

the tight linkage of obesity, insulin resistance (and frank diabetes), dyslipidemia, and hypertension has been widely observed and has been named syndrome x, or the metabolic syndrome. for many years metformin has been the only drug in clinical use with effects on insulin resistance. recently, agonists of the peroxisome proliferator-activated receptors (ppars) have been introduced in the treatment of type 2 diabetes. the different ppars seem to be activated by a wide range of lipids and lipid mediators, including fatty acids. 2-tetradecylthioacetic acid (tta) is a modified fatty acid with high affinity for the ppargamma receptor. in animal models of obesity-related insulin resistance (obese zucker rats and dietary manipulated wistar rats), tta has an insulin sensitizing effect by enhancing the insulin mediated uptake of glucose in peripheral tissues. tta treatment promotes fatty acid catabolism in experimental animals and this could casually be linked to the improved glucose tolerance. the protocol for the present study describes a safety assessment and therapeutic exploratory evaluation of tta in a small subset of male type 2 diabetes patients for 4 weeks. the primary safety parameters will include general physical observational parameters, liver function test and hematological parameters. to goal is to assess the efficacy of tta on selected metabolic parameters including fasting blood glucose and insulin, fasting plasma lipids, antioxidant status, and fibrinolytic parameters, weight, bmi and blood pressure.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus with hba1c 8.0-12.0%, * fasting s-triacylglycerol 2.0-10.0 mmol/l, * body mass index 25-40 kg/m2 and/or waist/hip ratio \> 0.90. exclusion criteria: * fasting total cholesterol \>10 mmol/l, * blood pressure 170/110 mmhg * other significant disease * use of any corticosteroid, anticoagulant or lipid-lowering drug 2 weeks prior to inclusion.
efficacy of diluted betadine vs antibiotic installation before surgical wound closure in prevention of post cardiac surgery wound infection

Conditions: Surgical Wound Infection

Summary: 1. infection control and health-care-associated infections and safety of medical service providers 2. evidence based management of common medical and surgical problems

surgical wound infection is the presence of replicating micro-organisms within a wound of a surgery leading to host injury. superficial sternal wound infection (sswi) is the infection that affects the skin and subcutaneous tissues and the pectoralis fascia(1,2). deep sternal wound infection (dswi) is the infection affecting muscle layer and the bony sternum, it is one of the most complex and potentially devastating complications following median sternotomy in cardiac surgery with a significant impact on both patient prognosis and hospital budgets, despite of many advances in prevention, it is still remaining significant, and ranges between 0.5% and 6.8%(2), with in-hospital mortality between 7% and 35%. moreover, mid- and long- term survival is significantly reduced in patients that have experienced dswi(3). sternal dehiscence is the process of separation of bony sternum which is often accompanied by mediastinits(4). although prevention of infection following arthroplasty requires a multifaceted approach, the use of intraoperative irrigation is an important component of any protocol. recent clinical practice guidelines from the centers for disease control, world health organization, and international consensus meeting on musculoskeletal infection advocate the use of a dilute povidone-iodine solution prior to wound closure. this experience suggests that this practice is safe, inexpensive, and easily implemented(5). the present study is going to discuss the effect of dilute povidone-iodine irrigation vs vancomycine irrigation intraoperative in prevention of postoperative infection after cardiac surgery.

Eligibility criteria:
inclusion criteria: * age from 1 to 65 years, primary or redo cases exclusion criteria: * diabetic patients
digital literacy and emotional intelligence and professional burnout among doctors

Conditions: Digital Competences; Emotional Intelligence; Emotional Burnout; Doctor Patient Relation

Summary: the role of digital technologies in healthcare is growing. therefore, the roles and responsibilities of medical professionals are constantly changing and there is a need for continuous professional development. however, according to some authors, today's generation of doctors can be considered as "digital aborigines" \[aungst, patel, 2020\]. low literacy in the field of e-health has become a major obstacle to digital transformation in developed countries, so digital skills training for healthcare professionals has gradually been introduced in the usa \[adler-milstein, et al., 2014\], europe \[schreiweis, et al., 2019\], australia \[evolution of ehealth in australia, 2016\]. however, in our opinion, the digital competence of a doctor is not only the ability to work at a computer and use software. the successful development of the digital world is preceded by some psychological and emotional processes. computerization and automation of the healthcare system began relatively recently, traditional (paper) document management in medicine is familiar to everyone, but not optimal from the point of view of system management. therefore, universal digitalization is perceived as something artificially imposed, increasing the workload of doctors, distracting from their main work and shifting the focus from truly therapeutic activities to filling out documentation. as a result, doctors have a range of negative emotions: fear, annoyance, anxiety, despondency, refusal of further contacts, etc., which lead to an aggravation of emotional burnout. the ability to recognize and live through these states, to come to an inner balance, to accumulate an internal resource for further development of new technologies - all this is possible under the condition of the development of emotional intelligence. by developing so-called soft skills, the doctor will be emotionally stable, capable of further advancement and learning new skills, and will easily cope with temporary difficulties and setbacks. and the final stage, having gained the opportunity to overcome internal obstacles, the doctor is ready to begin mastering specialized digital skills directly related to medical activities: work in medical information systems, remote monitoring, artificial intelligence, medical decision support systems. the result of the development of a doctor within this model will be not only digital literacy, but also the development of an internally stable personality that easily overcomes any obstacles not only in training, but also in communication with patients and colleagues.


Eligibility criteria:
inclusion criteria: * respondent has higher medical education * he is an employee of the any medical department at this moment exclusion criteria: * there is no higher medical education * does not work in medicine at this moment
pulse wave velocity, pulse wave morphology and blocking of the reninangiotensin system in patients with chronic kidney disease

Conditions: Kidney Failure, Chronic; Cardiovascular Diseases

Summary: the purpose of this study is to determine whether a combination therapy with angiotensin-converting enzyme (ace)-inhibitors and angiotensin receptor blockers reduces the arterial stiffness assessed by applantiontonometry more than a single treatment in kidney patients.


Eligibility criteria:
inclusion criteria: * creatinine: 150-350 micromol/l * blood pressure \> 110 systolic * negative pregnancy test for fertile women * written and oral informed consent from the patient exclusion criteria: * treatment with both ace-inhibitors (ace-i) and angiotensin receptor blockers * pregnancy or breastfeeding * treatment with immunosuppressive medication, steroids or non-steroidal anti-inflammatory drugs (nsaids) * serious chronic heart failure (new york heart association \[nyha\] iii-iv) * chronic liver disease * suspicion or verified kidney artery stenosis * cardiac arrhythmia and/or implanted pacemaker * myocardial infarction or cerebrovascular incidence within the last 3 months * allergy towards ace-i or angiotensin receptor blockers * amputation of a whole extremity or the crural or femoral part of the leg * dementia or a psychological condition that makes understanding of the examination conditions impossible * dialysis or renal transplantation * treatment with aldosterone antagonists * hyperkalemia \> 5.5 mmol/l * another serious chronic non-renal disease

Keywords: angiotensin-converting enzyme inhibitors type 1 angiotensin receptor antagonists blood pressure
improvement of left ventricular ejection fraction in icd patients undergoing therapy with sacubitril/valsartan

Conditions: Heart Failure

Summary: the study is aimed to evaluate the improvement of the left ventricular volumes and of the left ventricular ejection fraction in a population of icd patients with heart failure and left ventricle systolic dysfunction undergoing therapy with sacubitril/valsartan (according to current guidelines), during a 6-month follow-up.

consecutive, unselected patients with heart failure and left ventricle systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator (icd) for primary prevention of sudden death, undergoing therapy with sacubitril/valsartan (according to current guidelines) will be enrolled in the study. a two-dimensional echocardiogram with evaluation of left ventricular end-diastolic volume, left ventricular end-systolic volume, and left ventricular ejection fraction will be performed, according to standard clinical practice, at the beginning of the observation, and at a 6-month follow-up. the improvement of the left ventricle volumes and of the left ventricular ejection fraction will be evaluated.

Eligibility criteria:
inclusion criteria: * heart failure * left ventricular systolic dysfunction * carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death * undergoing therapy with sacubitril/valsartan according to current guidelines exclusion criteria: * age \<18 years
a study of pegasys (peginterferon alfa-2a (40kd)) plus copegus (ribavirin) with or without pioglitazone in treatment-naive patients with chronic hepatitis c and insulin resistance.

Conditions: Hepatitis C, Chronic

Summary: this 2 arm study will assess the efficacy and safety of pegasys plus copegus, with or without concomitant pioglitazone, on hepatitis c virus titers in treatment-naive patients with genotype 1 chronic hepatitis c, and insulin resistance. patients will be randomized to receive either a)pegasys 180 micrograms/week + copegus 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by pegasys 180 micrograms/week + copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. the anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic hepatitis c, genotype 1; * insulin resistance. exclusion criteria: * other forms of liver disease; * cirrhosis; * previous treatment for chronic hepatitis c; * insulin treatment during prior 2 weeks; * type 1 diabetes.